ELIPSE 14,000.014 CORONARY DILATATION CATHETER
FDA premarket approval P810046/S168 · decided 1997-04-21
Approval details
- PMA number
- P810046
- Supplement
- S168
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ELIPSE 14,000.014 CORONARY DILATATION CATHETER
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Date received
- 1996-08-22
- Decision date
- 1997-04-21
- Days to decision
- 242 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- APPROVAL FOR THE USE OF A NEW ADHESIVE IN THE MANUFACTURING OF THE ACS RX ELIPSE(TM) .014 CORONARY DILATATION CATHETER
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